FDA.reportPublic FDA data

Geri-Dryl allergy relief

Product NDC
57896-681
Requested package NDC
57896-681-10
11-digit product format
578960681
Labeler code
57896
Product ID
57896-681_cee221b6-e03a-1f47-e053-2995a90a0702
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
part336
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-01
Marketing end
2022-05-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57896-68157896-681-10DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-681-01EA - Each57896-681e29344a5-ad08-43c9-972b-beb568f5699f12015-09-10
57896-681-10EA - Each57896-681aa65f14f-e69d-483b-83f4-9ae63134d7ff12017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNa2f31f98-b89a-8e66-e053-2995a90a70ac1
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDa2f31f98-b89a-8e66-e053-2995a90a70ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-681-10578960681101000 TABLET, COATED in 1 BOTTLE (57896-681-10) 2012-11-012022-05-01NoNoCurrent